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A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma

A Phase 2, Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma (FLC)

NCT02234986•CASI Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine whether once-daily dosing with ENMD-2076 will be a safe and effective treatment in patients with FLC. Safety will be measured by looking at the adverse events that may happen and the efficacy will look at the progression of the disease over time.

Detailed Description

Primary Objective: • To determine the 6-month progression free survival (PFS6) rate when patients with advanced fibrolamellar carcinoma (FLC) are treated with daily oral ENMD 2076 Secondary Objectives: * To evaluate the overall response rate using RECIST v 1.1 criteria when patients with FLC are treated with daily oral ENMD 2076. * To evaluate the median Progression Free Survival (PFS), Time to Progression (TTP), and Overall Survival (OS). * To determine the safety of ENMD-2076 as defined by the frequency and severity of adverse events when patients with FLC are treated with daily oral ENMD-2076

Eligibility

Age

12 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC).
•All forms of prior local therapy are allowed as long as patients have either a target lesion, which has not been treated with local therapy and/or the target lesion(s) within the field of the local-regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
•Are at least 4 weeks from major surgery and recovered.
•At least one measureable lesion by RECIST 1.1.
•Male or non-pregnant, non-breastfeeding female at least 18 years of age. Patients aged at 12\~18 years may be recruited but only at the site principle investigator's request and subject to Institutional Review Board (IRB) approval.
•Has a pre-study echocardiogram or multi-gated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institutional lower limit of normal within one month of initiating therapy.
•Have clinically acceptable laboratory screening results within certain limits specified below:
•* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
•* Total bilirubin ≤ 3.0 x ULN
•* Creatinine ≤ 1.5 x ULN or Cr Cl \> 60 cc/min
+5 more criteria

Exclusion Criteria

•Have active, acute, or chronic clinically significant infections or bleeding within the last 6 months or previous thromboembolic or hemorrhagic events during anti angiogenic therapy.
•Have uncontrolled hypertension (systolic blood pressure greater than 150 or diastolic blood pressure greater than 100) or history of congestive heart failure (AHA Grade 2 or higher).
•Have active angina pectoris, stroke or recent myocardial infarction (within 6 months).
•Have uncontrolled chronic atrial fibrillation.
•Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec in adults and 450 msec in pediatrics (\< 18 years).
•Have additional uncontrolled serious medical or psychiatric illness that in the point of view of the investigator can render the patient unable to receive therapy or make it unsafe to receive therapy.
•Require treatment with any of the exclusionary medications listed in Appendix D.
•Known untreated or unstable central nervous system (CNS) metastatic disease.
•Have persistent 2+ protein by urinalysis (patients with 2+ proteinuria that have a spot protein:creatinine ratio of less than 0.3 may be enrolled) or a history of nephrotic syndrome.
•Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current FLC diagnosis.

Locations (5)

CASI Site 03

San Francisco, California, United States

CASI Site 04

Aurora, Colorado, United States

CASI Site 02

Boston, Massachusetts, United States

Casi Site 01

New York, New York, United States

CASI Site 05

Dallas, Texas, United States

Key Dates

Start Date

October 1, 2015

Primary Completion Date

June 30, 2018

Completion Date

June 30, 2018

Last Updated

April 18, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Adult Hepatocellular CarcinomaAdvanced Fibrolamellar Carcinoma

Interventions

ENMD-2076

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma

Inclusion Criteria

Exclusion Criteria

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